Medicated Relief Patches

Medicated Relief Patches
SPL v5
SPL
SPL Set ID 3f5b4eee-49c4-408c-9af2-e7924c26ac63
Route
TOPICAL
Published
Effective Date 2018-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.1 g) Menthol (6 g) Salicylic Acid (10 g)
Inactive Ingredients
Hydrogenated Polydecene (550 Mw) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum Styrene/acrylamide Copolymer (mw 500000)

Identifiers & Packaging

Pill Appearance
Shape: square
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-01

Description

Active Ingredients Purpose Camphor 3.1% ......................Topical Analgesic Menthol 6.0% .......................Topical Analgesic Methyl Salicylate 10.0% .......Topical Analgesic


Medication Information

Description

Active Ingredients Purpose Camphor 3.1% ......................Topical Analgesic Menthol 6.0% .......................Topical Analgesic Methyl Salicylate 10.0% .......Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application.

Children under 12 years of age: consult physician.

Do Not Use:
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Active Ingredients

Active Ingredients Purpose

Camphor 3.1% ......................Topical Analgesic

Menthol 6.0% .......................Topical Analgesic

Methyl Salicylate 10.0% .......Topical Analgesic

Inactive Ingredients

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Indication and Usage

For temporary relief of minor aches and pains.

For External Use Only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use

Pain Relief Patch Label

Box of 60

NDC:72036-907-60



Other Information: Store in clean, dry place outside of direct sunlight. Protect from excessive moisture.

DIST. BY

HARRIS TEETER, LLC

MATTHEWS, NC 28105

When Using This Product
  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tightly
  • Do not use at the same time as other topical analgesics
  • Dispose of used patch in manner that keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away

Stop Use and Consult A Doctor
  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • if symptoms last more than 7 days or clear up and occur again with a few days


Structured Label Content

Uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application.

Children under 12 years of age: consult physician.

Do Not Use: (Do not use:)
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Active Ingredients

Active Ingredients Purpose

Camphor 3.1% ......................Topical Analgesic

Menthol 6.0% .......................Topical Analgesic

Methyl Salicylate 10.0% .......Topical Analgesic

Inactive Ingredients

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Indication and Usage

For temporary relief of minor aches and pains.

For External Use Only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use

Pain Relief Patch Label

Box of 60

NDC:72036-907-60



Other Information: Store in clean, dry place outside of direct sunlight. Protect from excessive moisture.

DIST. BY

HARRIS TEETER, LLC

MATTHEWS, NC 28105

When Using This Product (When using this product)
  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tightly
  • Do not use at the same time as other topical analgesics
  • Dispose of used patch in manner that keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away

Stop Use and Consult A Doctor (Stop use and consult a doctor)
  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • if symptoms last more than 7 days or clear up and occur again with a few days


Advanced Ingredient Data


Raw Label Data

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